A Phase I, Open-label, Randomized, Two Way Crossover Pharmacokinetic Study Comparing the Bioavailability of Acetylsalicylic Acid (ASA) After 5 Days Repeated Once Daily Administration of a Fixed Dose Combination Capsule of ASA 81 mg/Esomeprazole 20 mg and ASA 80 mg (European Aspirin Reference Product)

NCT01448031 Phase 1 COMPLETED

This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

Details

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	COMPLETED
Enrolment	54
Start date	2011-11
Completion	2012-04

Conditions

• Healthy

Interventions

• Capsule ASA 81mg/esomeprazole 20mg
• Acetylsalicylzuur Apotex Cardio

Primary outcomes

• pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2). — Day 5
  PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.

Countries

United Kingdom